Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075155
Company: CHARTWELL MOLECULAR
Company: CHARTWELL MOLECULAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/30/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75155ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/24/2014 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/075155Orig1s034ltr.pdf | |
| 11/09/2004 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 01/26/2001 | SUPPL-20 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/30/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/14/1999 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/2000 | SUPPL-10 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/27/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/27/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/2000 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/13/2000 | SUPPL-2 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 05/14/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/24/2014 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf | |
| 09/24/2014 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075155Orig1s034lbl.pdf |
ISOSORBIDE MONONITRATE
TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075522 | DEXCEL LTD |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200495 | TORRENT PHARMS |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |
TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075522 | DEXCEL LTD |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200270 | TORRENT PHARMS |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |
TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 216557 | AUROBINDO PHARMA |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075155 | CHARTWELL MOLECULAR |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210822 | DEXCEL LTD |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 210918 | RICONPHARMA LLC |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 214115 | SHANDONG |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 200495 | TORRENT PHARMS |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | 120MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 075395 | ZYDUS HLTHCARE |